FDA opens comment periods on two issues regarding Substantial Equivalence Requirements

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DustyZ

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1. E-Cigs are not within the definition of "smokeless". Smokeless is a class, which does not include e-Cigs
2. The language "tobacco products have been found to be not substantially equivalent to specific predicate products due to factors such as inadequate evidence that the proposed predicate products were valid predicates and lack of complete information on the characteristics of the new products and the predicate products........all of this is fine for E-Cigs, who cares about analog products being rejected. E-Cigs are the same as each other, always. Its a electric coil, in contact with e-liquid, no combustion, heating the fluid to a Vapor, and there is NO filtration. They will have to recognize it as the same, because it is. If you read the items in the first message by the OP, you see the language is a big positive for E-Cigs.

Again, I ask what is your qualifications to make such statements regarding the legality of what or what cannot be done in regards to any Government ruled agency? What information do you have that makes you seem to know exactly what and how the FDA is going to process and deem e-cigarettes? How many times does it need to be made clear to you by Kristen and others that the FDA has not classified E-cigarettes as a tobacco product at this point! Also and that these entities are going to have a lengthy process by which they will need to submit documentation as to why the products are substantially equivalent.

At this point these threads are being beat to death with your supposition in a way that you seem to know all the legalities, exactly what and how the FDA is going to handle these issues.

Seems you are not taking into consideration the bureaucratic nature of FDA and that fact that not everything the do is logic based and typically takes is own stance on it's determinations. In addition this will cost suppliers a substantial amount of financial backing to submit what will be needed in the hops that they can prove the product as substantially equivalent.

So until such a time that you provide a background either as a legal a governmental expert, or that you have a magic crystal ball or are the reincarnation of Nostradamus, I will go by what those that are actually in the front lines indicate what they feel needs and has to be done!
 

Rossum

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The practice for analog Tabacco, and E-Cigs will be vastly different because of the thousands of chemicals [...]An E-Cig is a simple devises, with a handful of parts, and with a simple liquid. [...] As the E-Cigs are the same [...] Analogs are a widly more complex and different product than E-Cigs, there are not 3500 substantial variants in E-Cigs. [...] E-Cigs don't have this problem, its just the Vapor of the liquid, nothing else. The liquid is 4 core ingredients.
Except for the flavors. How many thousands of "chemicals" are in the flavors, and how many combinations and permutations of them exist? I could easily see the FDA requiring each and every flavor from every vendor to be submitted for "approval" and any change in ingredients in those flavors to require proof of "substantial equivalence".

Nichrome: Most heating elements use Nichrome 80/20 (80% nickel, 20% chromium) wire, ribbon, or strip. Nichrome 80/20 is an ideal material, because it has relatively high resistance and forms an adherent layer of chromium oxide when it is heated for the first time. Material beneath this layer will not oxidize, preventing the wire from breaking or burning out.
And of course, both chromium and nickel are completely non-toxic, right? Oh wait, they're not. Meaning if the FDA is so inclined, it could order the manufacturers to engage in tests and "studies" to prove that their particular coil design doesn't emit any toxic nickel or chromium compounds. Then of course there's the silica wick. There's no way that any small particles of silica could ever end up in the vapor, right? Well, I rather doubt it, but again, I could see the FDA demanding PROOF.

From a personal perspective, I don't give a darn what they do. I will have enough nicotine base and gear to last me indefinitely before they announce whatever regulations they're going to come out with. Worst case, I'm willing ignore their rules and simply buy stuff on the free ("black") market. So for me, it doesn't really matter. But it makes a big difference for the millions who have not yet discovered the obvious health benefits substituting vapor for smoke.
 

2coils

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Except for the flavors. How many thousands of "chemicals" are in the flavors, and how many combinations and permutations of them exist? I could easily see the FDA requiring each and every flavor from every vendor to be submitted for "approval" and any change in ingredients in those flavors to require proof of "substantial equivalence".
A really good point. We all say e-cigs have only four base ingredients, but some folks DO forget that the ingredients themselves have ingredients. I am not trying to indicate that any of them can be compared to traditional tobacco cigarettes, but trying to keep it real.
 

kristin

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When CASAA presented that a Provari battery could be banned, it just is not in the context of the real world.
When has CASAA said ever that??

OK, I take it back. Although "CASAA" (as an organization) hasn't presented that batteries could be banned, I just saw this post from Elaine in that other thread.

Do a search for "2007" and you will learn why Bill Godshall believes that a regulation that deems e-cigarettes to be a tobacco product could eliminate many of the more advanced products from the market. [Here's a little hint. Back in 2007 there was no such thing as an eGo, a Provari, a Chuck, or even a Joye 510. At best, we could be stuck with the very primitive models that didn't deliver nicotine very effectively. At worst, the FDA can say that there were NO models being sold in 2007, which would be a de facto ban.]

While I don't really share Bill and Elaine's concern that devices sold separate from e-liquid would be pulled under FDA control, it is a concern for some people that the FDA would deem devices that are intended to be used with nicotine e-liquids under its jurisdiction. The FDA has the opportunity under FSPTCA to create new regulations that are specific to e-cigarettes and it could decide to regulate the devices intended to deliver e-liquid, as well. After all, the FDA has issued rules on rolling papers and even matchbooks that are sold separately from tobacco and has rules on "parts" of tobacco products that are not actual tobacco, such as the filters. There is a possibility, no matter how remote, that it could decide to make rules on "tobacco product devices," too.

Personally, I cannot see that happening, because it would be a nightmare for the FDA to do it. It really would be only able to go after companies that clearly advertise their products as being intended to be used for e-liquids containing nicotine, which are the only liquids the FDA will be regulating. A company probably could easily get around that by stating "Not for use with liquids containing nicotine." Not only that, but a lot of companies sell devices in parts and do not sell liquids.

That said, any devices sold pre-filled or along WITH nicotine liquids would definitely be subject to the FDA regulations and it is quite feasible that the FDA could choose to regulate those particular devices. The FDA could also create regulations specific to e-liquid that prohibit selling nicotine liquid outside of a pre-filled cartridge. THAT is a bigger worry for me, since that definitely would affect what devices we would be able to use. Because if e-liquid is only allowed to be sold in pre-filled, sealed cartridges that the FDA approves, things like tanks and drip tips would be rendered useless. Could you imagine using an old-style, pre-filled cartridge on a Provari?

These are the issues that CASAA has been bringing up to the FDA and OMB regarding the potential elimination of diversity in the market and unintended consequences. It's a lot of "coulds" and mights," but they are things we had to consider in order to try to ensure that they don't happen. Because the FSPTCA doesn't currently have any regulations specific to e-liquid, once the FDA deems e-liquids to be "tobacco products," it has the authority to create regulations for them. Under these new regulations, there would be nothing to stop the FDA from requiring e-liquid tobacco products to be sold only in a specific way (ie. in pre-filled cartridges, not in bottles, banning certain flavors, setting a nicotine limit, etc.) And before someone ;) says that the FDA would not have this power, Sec. 907.1.3 of FSPTCA states:

"In general.--The Secretary may adopt tobacco product standards in addition to those in paragraph (1) if the Secretary finds that a tobacco product standard is appropriate for the protection of the public health."

So, if the FDA decides that pre-filled cartridges, restrictions on flavors and limits on nicotine strengths are "appropriate for the protection of the public health" (ie. protecting children), then it can adopt those as tobacco product standards specific to just the e-liquid tobacco products.
 
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k3vin

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Again, I ask what is your qualifications to make such statements regarding the legality of what or what cannot be done in regards to any Government ruled agency? What information do you have that makes you seem to know exactly what and how the FDA is going to process and deem e-cigarettes? How many times does it need to be made clear to you by Kristen and others that the FDA has not classified E-cigarettes as a Tobacco product at this point! Also and that these entities are going to have a lengthy process by which they will need to submit documentation as to why the products are substantially equivalent.

At this point these threads are being beat to death with your supposition in a way that you seem to know all the legalities, exactly what and how the FDA is going to handle these issues.

Seems you are not taking into consideration the bureaucratic nature of FDA and that fact that not everything the do is logic based and typically takes is own stance on it's determinations. In addition this will cost suppliers a substantial amount of financial backing to submit what will be needed in the hops that they can prove the product as substantially equivalent.

So until such a time that you provide a background either as a legal a governmental expert, or that you have a magic crystal ball or are the reincarnation of Nostradamus, I will go by what those that are actually in the front lines indicate what they feel needs and has to be done!


I second the above motion ,so far Tom,you just seem to be coming off as totally anti-casaa.
 

tombaker

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When has CASAA said ever that??

This is the position of CASAA as expressed by the President of CASAA

"Do a search for "2007" and you will learn why Bill Godshall believes that a regulation that deems e-cigarettes to be a tobacco product could eliminate many of the more advanced products from the market. [Here's a little hint. Back in 2007 there was no such thing as an eGo, a Provari, a Chuck, or even a Joye 510. At best, we could be stuck with the very primitive models that didn't deliver nicotine very effectively. At worst, the FDA can say that there were NO models being sold in 2007, which would be a de facto ban.]"

1. They can not ban the raw hardware, because, just like other hardware for other items, they are still sold. Its as if the President of CASAA has never been inside some of the local shops that sell APV hardware. This is plain as day.

2. The 2007 date has been all but dismissed by regulatory attorneys because of the retroactive premise. The law never contemplated E-Cigs, the products are being sold, and the FDA has yet to make them part of the Tobacco control act. I have posted that information already.

3. CASAA has a best case scenerio that Provari, and Ego, will be banned. That is the CASAA best case. Its ludicrous of CASAA to be selling this notion.

4. Worse case by CASAA is the defacto ban theory, that CASAA is pumping. Claiming the FDA can ban everything, even though the law they operate on says they can not do so.

5. CASAA is basically a user group, which sends out blast emails, all of that is fine, except the legal information they are presenting is wrong. Wrong is wrong. You can not go outside the letter of the law.

So CASAA thinks the Provari battery, with can be banned....its the height of unnecessary panic. Meanwhile local usage bans are being unattended, and ineffectively handled. CASAA is going around saying that anti-smoking advocates don't care if people live or die. Hard to take any organization that offers that out, with serious credibility, especially when they take that to public agenda of localities.

The FDA can not ban a battery....CASAA is wrong
 

tombaker

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Again, I ask what is your qualifications to make such statements regarding the legality of what or what cannot be done in regards to any Government ruled agency? What information do you have that makes you seem to know exactly what and how the FDA is going to process and deem e-cigarettes? How many times does it need to be made clear to you by Kristen and others that the FDA has not classified E-cigarettes as a Tobacco product at this point! Also and that these entities are going to have a lengthy process by which they will need to submit documentation as to why the products are substantially equivalent.

At this point these threads are being beat to death with your supposition in a way that you seem to know all the legalities, exactly what and how the FDA is going to handle these issues.

Seems you are not taking into consideration the bureaucratic nature of FDA and that fact that not everything the do is logic based and typically takes is own stance on it's determinations. In addition this will cost suppliers a substantial amount of financial backing to submit what will be needed in the hops that they can prove the product as substantially equivalent.

So until such a time that you provide a background either as a legal a governmental expert, or that you have a magic crystal ball or are the reincarnation of Nostradamus, I will go by what those that are actually in the front lines indicate what they feel needs and has to be done!

Very long winded way of saying to ignore me. There are plenty of lawyers that have published papers on this topic, contradicting what the CASAA is selling. E-Cig vendors are not panicked, and many welcome the regulations. The law is the law.

The FDA has said it won't fight the Sottera decision, and it intends to deem E-Cigs as a Tobacco product, and is in the process of doing so. Its going to happen, it is in process.

Much of the hype of the defacto ban is pushed aside by the fact that the Sottera decison was 2 years ago, and the FDA has not moved since. Be afraid, be very afraid.
 

tombaker

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It's a lot of "coulds" and mights," but they are things we had to consider in order to try to ensure that they don't happen.

You don't have to consider the impossible, to insure the impossible does not happen. Meanwhile while mights and totally legally unfounded "coulds" are being sold, there are real issues with local bans.

CASAA has the legal opinion that batteries can be banned. This is emblematic of their entire legal analysis of the FDA. The legal foundation of what the CASAA is claiming is just not there, and the whole house built on top of it, is a deck of playing cards, a breeze of vape, blows it all down.

V2, BLU, Apolloecigs, NJoy, are all going to do the work on the FDA. They have their jobs associated with making sure it goes right. CASAA is a user group of Vapers.

This thread is about the good news coming out of the FDA, or actually the news coming out of the FDA, and I think it is good for vapors.

When the CASAA gets on the same page of V2 and BLU it will go a long way. But opinions that APV hardware will be banned, and that the FDA is signalling that APV hardware will be banned, is disinformation.

All the chicken little energy worrying about the Sky Falling is working by CASAA theory, the Sky has not fallen. CASAA worries much that the Provari will be taken away, meanwhile there is reality. Read the first post by the OP
 

DustyZ

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Very long winded way of saying to ignore me. There are plenty of lawyers that have published papers on this topic, contradicting what the CASAA is selling. E-Cig vendors are not panicked, and many welcome the regulations. The law is the law.

The FDA has said it won't fight the Sottera decision, and it intends to deem E-Cigs as a Tobacco product, and is in the process of doing so. Its going to happen, it is in process.

Much of the hype of the defacto ban is pushed aside by the fact that the Sottera decison was 2 years ago, and the FDA has not moved since. Be afraid, be very afraid.

Nope, I never said ignore you and you are putting words in my mouth! However again, you keep stating this they can't do this or they can't do that as it is the law! However, you seem to like to skirt any direct questions put to you and use information from, well who knows where. I simply asked what your legal expertise is and what makes you have all of this inside knowledge of what the FDA can or cannot due. I have yet to see one piece of anything that you have stated that comes from you that doesn't in one way or another fall a bit flat and you had been asked before by others to show documentation as to all this proof of a LEGAL stand point in your personal arsenal. If you are not an attorney, para-legal, attended law school in any manner, work for an attorney that is handling similar types of issues, then this is all supposition on your part, however you keep making all these statements as if you have all the answers on a subject that has not been firmly addressed by the FDA or any other legal, government agency other the city ordinances that have been taking hold. These are taking hold due to the fact that there is no Federal Mandate on this subject at this point.

And as much as I would like to believe in some of the things you are stating are gospel, I will believe it when it actually happens. You come off in a way that indicates that you have all the answers and that CASAA doesn't and doesn't have any in-depth knowledge of what is brewing despite the fact that have and are dealing with information on a daily basis. I yet to see any documentation of yours that lends credence to your what is at this point supposition and no concrete answers of how you are so much more knowledgeable then anyone else!

You have the gall to say that I was long winded, well take a look in the mirror, your posts and responses are a heck of a lot more long winded as mine are. Real credible!
 
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SloHand

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Very long winded way of saying to ignore me. There are plenty of lawyers that have published papers on this topic, contradicting what the CASAA is selling. E-Cig vendors are not panicked, and many welcome the regulations. The law is the law.

You know Tom, I like a lot of what your saying but you've totally side stepped DustyZ question by deflecting. Legal opinion isn't just posted on the interweb. It's paid for. Any searches I've done doesn't pull up any "legal opinions" supporting the position you espouse here just a ton of speculation just like yours. I come to this site for information and the information that I generally find acceptable is the information that is quoted from source posters claim or with links to those alternate opinions.

What legal opinions are you privy to that we are not? Your position sounds good but up until now it's just fiction. CASAA and Bill both have impeccable sources (and pedigree). Other than reading and interpreting some very complex law and government bureaucracy, what are these supporting legal opinions?

I'm ready to jump on your bandwagon but I don't see the cavalry? Not everyone here is going to do the in depth analysis you've done. Like the Pakleds "make us smart", "make it go" (Star Trek Reference).
 

tombaker

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You know Tom, I like a lot of what your saying but you've totally side stepped DustyZ question by deflecting. Legal opinion isn't just posted on the interweb. It's paid for. Any searches I've done doesn't pull up any "legal opinions" supporting the position you espouse here just a ton of speculation just like yours. I come to this site for information and the information that I generally find acceptable is the information that is quoted from source posters claim or with links to those alternate opinions.

What legal opinions are you privy to that we are not? Your position sounds good but up until now it's just fiction. CASAA and Bill both have impeccable sources (and pedigree). Other than reading and interpreting some very complex law and government bureaucracy, what are these supporting legal opinions?

The OP of this thread posted some very good information that is available for public comment. If you read it, the guides for substantial equivilance are very reasonable, and something that E-Cigs should be able to hurdle with ease. People seem worried that small shops brewing in their backroom will not be able to sell e-juice online. I doubt it, because the ablity to get past the hurdles won't be so hard. If they don't want to be a member of MEMBERS | AEMSA frankly I don't care if they continue, sorry. AEMSA members will be able to get their papers filled out, they will help each other. AEMSA is a real orgainizaiton making a difference. I see a lot of posts by CASAA but their website is not up to date with anything in the way of accomplishments except from years ago, and those I debate if CASAA was just simply in attendance. I guess I am a tough grader. Not sorry.

Yes I read, and I read what the OP post. I read Sottera. You can read some of what I post below, I did not write it. I am not here to spoon feed everyone the raw information that can be read.

I see on the top of every thread in this forum a call to action, that is years old. It mostly displaced by the Sottera decision and what the FDA has said it is giong to do......but they still have not. When CASAA puts out a battery, (voltage regulated with some nice gizmos, but its still just a power source of DC current....a battery) can be banned and taken off the market.....it shows how many years backwards, and legally wrong. Its a false protrayal of reality of what the FDA is going to do, but I won't tell you you should not donate money to those opinions, its your choice. Factually that presentation by the President of CASAA, citing Godshall.....it just junk. And as I and others are saying, screw on a LED on the end of a Provari, which would be a lovely addition to the box set, and you have an expensive flashlight. It won't come off the market, EVER, unless they themselves want to stop selling it.

So when faced with all this junk and FUD, sky is falling talk, I think its waste of time. Meanwhile tons of local bans are not a waste of time. That has always been my point. CASAA is one of many duplicative information sources of what is going on, but its entirely not effective in doing anything to stop the onlsalught of bans. CASAA has just not been the answer. And I don't want to say they are not trying, they did. Bans are rolling over people, for example the entire UC University system. Maybe its easier to work the problem of what the FDA may do years down the road. Sottera was 3 years ago. But every day, E-Cigs are being sold, large players, TV ads...time marches on.

My point has never been that I am the answer to the question, I know you folks want to go there. The question remains with or without me. I am attempting to refocus where the effort needs to happen. The FDA is a false concern, Bans are where the action is, telling someone a meeting is going down, is nice and all, but writing your Congressman, and your Senator, is going to do NOTHING. Its all on the local level.

Perhaps consider this:
Judge Merrick B. Garland concurred with the majority, but not entirely for the same reasons. Like the majority, Judge Garland agreed that based on the plain language of the Tobacco Act, Sottera’s e-cigarettes fall within meaning of “tobacco product” because the liquid nicotine used in those products is derived from tobacco plants. Therefore, e-cigarettes should be regulated as tobacco products and not drug-delivery devices. However, Judge Garland did not agree that the holding in Brown extended to the e-cigarette situation.

Rather, he stated that the Supreme Court’s decision was only meant to apply to products that actually contain tobacco which e-cigarettes do not.

According to Judge Garland, the reason the Supreme Court in Brown held that FDA did not have jurisdiction to regulate customarily marketed tobacco cigarettes as drug-devices was because such products allegedly could not be used safely for any therapeutic purpose, and would thus have to be banned by FDA if the Agency had drug-device authority over them.

However, this premise does not hold true for e-cigarettes or other tobacco-free products that deliver pure nicotine; these types of products could have therapeutic benefits and would not necessarily have to be banned. Finally, Judge Garland acknowledged FDA’s argument that its interpretation of the Tobacco Act, as the Agency charged with interpreting the new law, should be entitled to deference (i.e., Chevron deference).30 The Judge stated, however, that because there was no final agency action from FDA interpreting the new law, there was no way
to award such deference to the Agency’s position. He concluded with the following: “What the result would be were the FDA to offer a contrary statutory interpretation in the form of a regulation, I leave for the day the agency decides to take that step.”

On December 20, 2010, FDA, refusing to accept what appeared to be inevitable, filed a Petition for a Rehearing and a Rehearing En Banc, as well as a motion to reinstate the stay of the District Court’s decision to grant Sottera’s preliminary injunction, arguing that the panel’s decision was based on a “fundamental misunderstanding” of the Brown decision. FDA contended that the panel’s ruling would erode incentives for companies to develop nicotine replacement therapies, and would “exacerbate the problem of nicotine addiction and undercut an important tobacco control measure.” On January 24, 2011, the Court of Appeals unanimously denied the FDA’s en banc rehearing request and left in place the injunction preventing FDA from barring e-cigarette imports and from regulating the products as drug-devices.

The ruling underscored the panel’s original decision and forced FDA to consider the extent to which it should regulate e-cigarettes under the Tobacco Act, or appeal to the Supreme Court.

Although e-cigarettes will not require FDA’s pre-market approval to be sold, FDA will be able to use its authority under the Tobacco Act to ensure that appropriate age and marketing restrictions are in place, and also require e-cigarette manufacturers and distributors to disclose all ingredients, additives and any potentially harmful constituents used in their products.

----------------Your Tanks and Provaris, are not going to be banned.....CASAA admittedly published...it can happen.....nope, legally wrong, sorry if you don't understand. If its from the President of CASAA, it is CASAA, sorry Kristin, the President speaks for the Organization, that is why they are the President.
 

soba1

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My point has never been that I am the answer to the question, I know you folks want to go there. The question remains with or without me. I am attempting to refocus where the effort needs to happen. The FDA is a false concern, Bans are where the action is, telling someone a meeting is going down, is nice and all, but writing your Congressman, and your Senator, is going to do NOTHING. Its all on the local level.

Nothing is ever a waste especially since we are getting hit on so many fronts.
Showing up en masse at local town meetings is big. The squeaky wheel gets
the grease those that are articulate and can afford to show up should.
I went to the meeting in LA. There were two stuff suits reading from a darn paper
in opposition to ecigs. The vapers that showed up blew them out of the water.
I would tend to agree with you with the onslaught of local vaping bans might
be a tad more to worry about than the FDA. But then again the FDA should
not be ignored. Nothing should be ignored.

Heck I always use sports as an analogy, You don't win the big game with the long bomb.
you win it inch by inch yard by yard. Ali never walked in the ring and won with one big
punch he spattered his opponets with flurries. CASAA is taking care of the head shots.
What the CASAA does sending out notifications to show up at local meetings
is huge. Heck even when we see articles about ecigs post away baby, leave no stone
unturned.
We at the local levels need to keep our areas in check. If we suit up and show
up one municipality at a time we got this.

Heck how do you drive from LA to NY?
One mile at a time.

To win the battle for vapers now and in the future
no effort is too small or too great.
 

DC2

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The OP of this thread posted some very good information that is available for public comment. If you read it, the guides for substantial equivalence are very reasonable, and something that E-Cigs should be able to hurdle with ease.
I read it, and I don't think you have any idea what you're talking about.
It doesn't say anything different then what we already knew.

It is encouraging that the FDA is seeking comments though.
Perhaps they may be considering making substantial equivalence far less burdensome than it is now.

That would certainly be helpful, since at this time substantial equivalence is clearly just about impossible.
That much is obvious from their publicly documented reasons for denying such applications.
 
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